DISEASE-14: Clinical trials of innovative interventions for neurodegenerative diseases

Call goal: run early-stage clinical trials of a drug-based therapy combined with another approach (e.g. lifestyle, cognitive training, rehabilitation) for neurodegenerative diseases, and use imaging and omics to understand how it works and personalize it. Rare neurodegenerative diseases are excluded.

What we contribute:

·       Omics signatures (methylation, transcriptomic) of response to treatment, as candidate surrogate endpoints.

·       Genetic stratification of trial participants (e.g. risk variants) to support more personalized treatment.

·       PGx profiling to explain differences in drug exposure and safety in phase 1 and 2.

·       AI-based integration of omics with imaging and clinical data, plus FAIR data management.

·       Long-read detection of repeat expansions and structural variants, plus methylation from the same run, for deeper genetic characterization of trial participants.

·       API and LIMS integration to process trial samples in automated batches across sites.

·       GDPR-aligned, EEA-hosted data handling under ISO 13485 and ISO/IEC 27001, simplifying the ethics and data-protection requirements of the trial.

Why it strengthens the consortium: trial sponsors need the mechanistic and personalization evidence this call asks for but rarely have in-house omics and AI capacity. Geneyx provides it in one partner: omics signatures before and after treatment, genetic and PGx stratification, and AI integration with imaging and clinical data. This strengthens the proposal's mechanism-of-action and surrogate-endpoint aspects and covers the FAIR data management and links to genomic data infrastructures the call expects.